1. Access to HCV medicines and patent law Ellen ‘t Hoen, Medicines Law & Policy Seychelles September 2014

2. Background 185 million people across the world are infected with HCV; 150 million are chronically infected. The HCV pandemic is concentrated in middle-income countries (MICs) 15% of the 150 million people with chronic HCV live in high-income countries (HICs), 73% live in MICs 12% in low-income countries (LICs). It is estimated that HCV-related liver complications kill 350,000 people annually. Until recently treatment was cumbersome and not very effective Seychelles has approx. 440 cases of HCV

3. Direct Acting Antivirals New drug treatments: Direct Acting Antivirals (DAA) came to market in 2013 Simeprevir (formerly TMC435; trade name Olysio) marketed by J&J Sofosbuvir (Sovaldi) marketed by Gilead. Others in the pipeline Oral short course treatments 12- 24 weeks (to be taken together with one or two other products) Highly effective, provides a cure Recent WHO HEPC treatment guidelines recommend the use of DAAs.

4. The case of sofosbuvir Received marketing approval 6 Dec. 2013. Marketed by Gilead. In HICs, sofosbuvir is sold USD1,000 per pill or USD84,000 per person for 12 weeks United States – estimated 5,367,834 persons are infected with HCV. GNI/capita: USD52,340 France, the cost of sofosbuvir is set at US$913 per pill (US$76,720 per person for 12 weeks). GNI/capita: US$41,750 In MICs, Gilead plans to sell sofosbuvir for at least US$2,000 (for a 12-week course).

5. HCV Treatment Cost RegimenCost (US$)Duration (weeks) Olysio+Pegasys+ribavirin106,67348 Incivec+Pegasys+ribavirn106,46848 Victrelis+Peintron+ribavirin95,84548 Sovaldi+Pegasys+ribavirin94,07812 Olysio+Pegasys+ribavirin86,51624 Incivek+Pegasys+ribaviron86,32124 Victrelis+Peintron+ribavirin85,25736 Victrelis+Pegintron+ribavirin64,82528

6. Gilead Gilead: “We will defend the patents, but at the same time, we are going to be pushing very hard to enable generic production in India with multiple companies.” http://www.thehindubusinessline.com/companies/gilead-local-generic-players-in- talks-to-bring-hepatitis-c-drug-into-india/article5649841.ece http://www.thehindubusinessline.com/companies/gilead-local-generic-players-in- talks-to-bring-hepatitis-c-drug-into-india/article5649841.ece Gilead’s website: “HCV is also a key therapeutic focus area for Gilead, and we are working on programs and partnerships to ensure that, worldwide, those patients for whom treatment with Sovaldi® (sofosbuvir) may be appropriate have access to it.”

7. Pricing in LMICs Tiered pricing in certain low and middle income countries Generic availability in 60 low income countries Egypt, US$900 per treatment course. GNI/pc $2980. MSF: target cost for treatment: 500$ This is possible

8. Cost of Production Source: http://cid.oxfordjournals.org/content/early/2014/0 1/06/cid.ciu012.full.pdf+html http://cid.oxfordjournals.org/content/early/2014/0 1/06/cid.ciu012.full.pdf+html Production cost for 12 week treatment Ribavirin$21 - $63 Daclatasvir (BMS)$10 - $30 Sofosbuvir (Sovaldi -Gilead)$68 - $136 Faldaprevir (BI)$100 - $210 Simeprevir (Olysio-J&J)$130 - $270

9. Generic sofosbuvir Low cost production of generic sofosbuvir is possible Gilead applied for patents in India Pre-grant opposition pending in India

10. Treatment cost Treatment of 440 PLWHC @ full price– 37 mill $ Treatment @ 500$ - 220,000 $

11. Access Scenarios Originators lower the price to a level Seychelles an afford Originator grants voluntary licenses/ Medicines Patent Pool to generic manufacturers - Seychelles part of territory Patent not granted in India Patent not granted in Seychelles -> import from India Patent granted in Seychelles -> CL/GU -> import from India Patent granted in India -> Section 92(A) Indian Patents Act: CL for export to Seychelles Patent granted in Seychelles -> issue CL/GU SADC regional procurement -> larger orders to benefit from economies of scale – re-exportation from Seychelles to other SADC countries

12. Requirements TRIPS flexibilities included in Seychelles Patent Law. “Government use” of patents in procurement. Collaboration with other SADC countries to create economies of scale and demand by using the 30 th August 2003 waiver.